Liposomal Amphotericin B in Treating Granulocytopenia and... | NCT00003938 | Trialant
NCT00003938
Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
Status
Completed
Last Update Posted
Sep 24, 2012Estimated
Enrollment
115Actual
Phase
Phase 3
Conditions
Cancer
Interventions
liposomal amphotericin B
Countries
Belgium
Czechia
France
Germany
Greece
Hungary
Israel
Italy
Netherlands
Portugal
Slovakia
Spain
Sweden
Turkey (Türkiye)
United Arab Emirates
Protocol Section
Identification Module
NCT ID
NCT00003938
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
EORTC-19951
Secondary IDs
ID
Type
Description
Link
EORTC-19951
Brief Title
Liposomal Amphotericin B in Treating Granulocytopenia and Persistent Unexplained Fever in Cancer Patients
Official Title
A Strategic Study to Determine the Optimal Moment to Initiate Systemic Antifungal Therapy With Ambisome in Granulocytopenic Cancer Patients With Unexplained Fever Refractory to Empirical Antibacterials
Acronym
Not provided
Organization
European Organisation for Research and Treatment of Cancer - EORTCNETWORK
Status Module
Record Verification Date
Sep 2012
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jun 1999
Primary Completion Date
May 2003Actual
Completion Date
Not provided
First Submitted Date
Nov 1, 1999
First Submission Date that Met QC Criteria
Jan 26, 2003
First Posted Date
Jan 27, 2003Estimated
Results Waived
Not provided
Results First Submitted Date
Not provided
Results First Submitted that Met QC Criteria
Not provided
Results First Posted Date
Not provided
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Sep 20, 2012
Last Update Posted Date
Sep 24, 2012Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
European Organisation for Research and Treatment of Cancer - EORTCNETWORK
Collaborators
Not provided
Oversight Module
No data available
No data is available for this block.
Description Module
Brief Summary
RATIONALE: Liposomal amphotericin B may be effective in controlling fever and granulocytopenia. It is not yet known which regimen of liposomal amphotericin B is more effective in treating cancer patients who have these conditions.
PURPOSE: Randomized phase III trial to compare the effectiveness of two regimens of liposomal amphotericin B in treating granulocytopenia and fever in cancer patients.
Detailed Description
OBJECTIVES:
Compare the efficacy and side effects of amphotericin B-liposomal formulation initiated 72-84 hours vs 144-156 hours after onset of a febrile episode in cancer patients with granulocytopenia and persistent unexplained fever refractory to antibacterials.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to antifungal prophylaxis (yes vs no) and type of underlying condition. Patients are randomized to 1 of 2 treatment arms.
Arm I: Patients receive amphotericin B-liposomal formulation IV over 1 hour on day 3 of febrile neutropenia.
Arm II: Patients receive amphotericin B-liposomal formulation IV over 1 hour on day 6 of febrile neutropenia.
Treatment continues until signs and symptoms of the fungal infection appear or febrile neutropenia has resolved. Persistently neutropenic patients receive treatment for at least 10 days or until another cause of infection is determined.
Patients are followed weekly for 3 weeks.
PROJECTED ACCRUAL: A total of 450 patients will be accrued for this study.
Conditions Module
Conditions
Cancer
Keywords
stage I adult Hodgkin lymphoma
stage II adult Hodgkin lymphoma
stage III adult Hodgkin lymphoma
stage IV adult Hodgkin lymphoma
stage IV breast cancer
stage IIIA breast cancer
monoclonal gammopathy of undetermined significance
stage IIIB breast cancer
recurrent childhood acute lymphoblastic leukemia
recurrent adult Hodgkin lymphoma
stage I cutaneous T-cell non-Hodgkin lymphoma
stage II cutaneous T-cell non-Hodgkin lymphoma
stage III cutaneous T-cell non-Hodgkin lymphoma
stage IV cutaneous T-cell non-Hodgkin lymphoma
recurrent cutaneous T-cell non-Hodgkin lymphoma
isolated plasmacytoma of bone
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
115Actual
Arms/Interventions Module
Arm Groups
Not provided
Interventions
Name
Type
Description
Arm Group Labels
Other Names
liposomal amphotericin B
Drug
Outcomes Module
No data available
No data is available for this block.
Eligibility Module
Eligibility Criteria
DISEASE CHARACTERISTICS:
Hematologic malignancy or solid tumor
Must be undergoing remission induction and/or consolidation therapy for hematologic malignancy only OR
Must be undergoing allogeneic or autologous bone marrow transplantation
Granulocyte count less than 500/mm^3 and profound granulocytopenia expected to last for greater than 5 days
Fever (greater than 38.5 degrees C) refractory for greater than 72 hours and less than 84 hours to broad spectrum antimicrobials, after exclusion of current bacterial, fungal, viral, parasitic, and mycobacterial infections
Peripheral blood cultures and central venous catheter cultures negative for infections
No microbiological documentation of a bacterial infection (e.g., abscess at catheter site)
No invasive fungal infection
No probable noninfectious cause of fever
PATIENT CHARACTERISTICS:
Age:
Not specified
Performance status:
Karnofsky 40-100% OR
WHO 0-2
Life expectancy:
Not specified
Hematopoietic:
See Disease Characteristics
Hepatic:
Not specified
Renal:
Not specified
Other:
No prior anaphylactic reaction to amphotericin B
No psychological, familial, sociological, or geographical conditions that would prevent compliance
Not pregnant or nursing
Normal chest X-ray or normal high resolution CT scan of the lungs
PRIOR CONCURRENT THERAPY:
Biologic therapy:
See Disease Characteristics
Chemotherapy:
See Disease Characteristics
Endocrine therapy:
Not specified
Radiotherapy:
Not specified
Surgery:
Not specified
Other:
No concurrent active systemic antifungal agents or antifungal prophylaxis (e.g., azoles or polyenes)
No prior IV amphotericin B during same neutropenic episode
No change in antibacterial regimen within 48 hours prior to study
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
Not provided
Maximum Age
Not provided
Standard Ages
ChildAdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
P. Ljungman, MD
Karolinska Institutet
Study Chair
Locations
Facility
Status
City
State
ZIP
Country
Contacts
A.Z. St. Jan
Bruges
8000
Belgium
Institut Jules Bordet
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
No data available
No data is available for this block.
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
extramedullary plasmacytoma
refractory multiple myeloma
recurrent childhood rhabdomyosarcoma
stage II ovarian epithelial cancer
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer
recurrent ovarian epithelial cancer
disseminated neuroblastoma
recurrent neuroblastoma
recurrent Wilms tumor and other childhood kidney tumors
stage 0 chronic lymphocytic leukemia
Waldenstrom macroglobulinemia
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma
stage I childhood lymphoblastic lymphoma
stage II childhood lymphoblastic lymphoma
stage III childhood lymphoblastic lymphoma
stage IV childhood lymphoblastic lymphoma
recurrent childhood lymphoblastic lymphoma
stage I chronic lymphocytic leukemia
stage II chronic lymphocytic leukemia
stage III chronic lymphocytic leukemia
stage IV chronic lymphocytic leukemia
recurrent childhood acute myeloid leukemia
recurrent adult acute myeloid leukemia
recurrent adult acute lymphoblastic leukemia
relapsing chronic myelogenous leukemia
refractory chronic lymphocytic leukemia
small intestine lymphoma
stage III malignant testicular germ cell tumor
recurrent malignant testicular germ cell tumor
unspecified childhood solid tumor, protocol specific
unspecified adult solid tumor, protocol specific
chronic phase chronic myelogenous leukemia
accelerated phase chronic myelogenous leukemia
blastic phase chronic myelogenous leukemia
meningeal chronic myelogenous leukemia
adult acute myeloid leukemia in remission
adult acute lymphoblastic leukemia in remission
childhood acute myeloid leukemia in remission
childhood acute lymphoblastic leukemia in remission
polycythemia vera
primary myelofibrosis
essential thrombocythemia
fever, sweats, and hot flashes
childhood acute promyelocytic leukemia (M3)
testicular embryonal carcinoma
testicular choriocarcinoma
testicular teratoma
testicular yolk sac tumor
testicular embryonal carcinoma and teratoma
testicular embryonal carcinoma and teratoma with seminoma
testicular embryonal carcinoma and yolk sac tumor
testicular embryonal carcinoma and yolk sac tumor with seminoma
testicular embryonal carcinoma and seminoma
testicular yolk sac tumor and teratoma
testicular yolk sac tumor and teratoma with seminoma
testicular choriocarcinoma and yolk sac tumor
testicular choriocarcinoma and embryonal carcinoma